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Senior Staff Reagents Development Scientist
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Job Description
- Req#: 9153
- Applies established DFSS principles and tools to new product development in the Hemostasis and Acute Care Business Unit
- Drives formulation optimization in collaboration with the R&D project teams
- Drives critical parameter management studies for new products
- In collaboration with the R&D project teams and Medical Affairs/Clinical, designs and executes Monte Carlo simulations to predict clinical performance against predicates/reference tests
- Frequently communicates project status to stakeholders and across organization.
- Champions and mentors junior scientists on the use of DFSS tools/principles
- Assist in formulation optimization when design changes are required for on-market Hemostasis products
- In collaboration with the R&D and product support team, assist in QC method development for new products
- May direct the work of other personnel.
- Performs other related duties and responsibilities as assigned.
- Reasonable accommodation may be made to enable individuals with disabilities to perform these essential functions.
- Responsible for cross-functional collaboration to identify and implement technical solutions for new product development, sustaining, and life cycle management products.
- Frequent inter-organizational and outside contacts. May represent the company to outside organizations on technical issues
- Technical leadership, problem solving skills, effective time management, effective in building cross-functional relationships and effective communication.
- Experience in statistical analysis, exploratory data analysis, and data representation
- Experience applying DFSS/DMAIC methodologies to design and develop new in vitro diagnostic platforms
- Strong presentation and general communication skills, ability to work in teams
- Minimum of a BS degree, MS or PhD preferred.
- DFSS green or black belt certification required.
- Minimum of 10 years work experience in IVD product development
- Up to 5%.
Overview
The Senior Staff Reagents Development Scientist will leverage Designing for Six Sigma (DFSS) tools and principles to drive robust product design/development. This individual will employ advanced experimental design principles (e.g., DOE) to optimize reagent formulations. In collaboration with Operations/Product Support and System Engineering, this individual will ensure formulations are robust to manufacturing tolerances and system noise(s). This individual will serve as a DFSS champion and mentor.
Responsibilities
Networking/Key relationships
Skill and Capabilities
Qualifications
Minimum Knowledge & Experience for the position:
Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.
Travel Requirments
About the company
OEM Technology Center, a leading Center of Excellence in the R&D and manufacture of immunoassay and biomaterial solutions for the diagnostics industry.
Notice
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